dtap-ipv-hep b-prp~t combined vaccine versus dtap-ipv//prp~t combined vaccine + hep b vaccine in hep b primed infants

Conditions: Diphtheria; Tetanus; Pertussis; Haemophilus Influenzae Type b Infection; Poliomyelitis; Hepatitis B

Summary: the aim of this study is to evaluate the immunogenicity and safety of a novel dtap-ipv-hep b-prp\~t fully liquid combined hexavalent vaccine (study vaccine) administered at 2, 4, and 6 months of age compared to sanofi pasteur's dtap-ipv//prp\~t combined vaccine (pentaxim™) given at 2, 4, and 6 months of age and hep b vaccine (euvax b®) given at 1 and 6 months of age in south korean infants that received a birth dose of hep b and born to mothers documented to be serum anti-hbs ag negative. primary objective * to demonstrate the non-inferiority in terms of seroprotection (diphtheria, tetanus, poliovirus types 1, 2, and 3, prp-t, hep b) and vaccine response for pertussis antigens (pertussis toxoid \[pt\] and filamentous haemagglutinin \[fha\]) of group a versus group b, one month after the third dose of combined vaccines. secondary objectives: * to further study the immunogenicity of the two vaccination schemes, before the first dose and one month after the last dose of vaccines. * to study the safety after each and any dose of vaccines administered in the two vaccination schemes

study participants who received a first dose of recombinant hep b vaccine at birth will receive either dtap-ipv-hep b-prp\~t combined vaccine at 2, 4, and 6 months of age + 3 doses of hep b vaccine or hep b vaccine (euvax b®) at 1 and 6 months of age and dtap ipv//prp\~t combined vaccine (pentaxim™) at 2, 4, and 6 months of age, according to the official vaccination schedule for hep b, dtap, poliovirus, and hib vaccinations in south korea.

Eligibility criteria:
inclusion criteria: * aged 30 to 40 days on the day of the first study visit * born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg * informed consent form has been signed and dated by the parent(s) or other legally acceptable representative * participant and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures * born to known hepatitis b surface antigen (hbsag) seronegative mother (documented laboratory result of hbsag assay from the maternal blood sample is available) * have received one documented dose of hep b vaccine at birth according to the national recommendations. exclusion criteria: * participation in the 4 weeks preceding the trial inclusion or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure * receipt of any vaccine in the 4 weeks preceding any trial vaccination (except bacille calmette guerin (bcg) vaccine) or planned receipt of any vaccine in the 8 days following any trial vaccination * previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis b (except the dose of hep b vaccine given at birth) diseases or haemophilus influenzae type b infection with either the trial vaccine or another vaccine * past or current receipt of immune globulins, blood or blood-derived products or planned administration during the trial * known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, since birth; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth) * known personal or maternal history of human immunodeficiency virus (hiv) or hepatitis c seropositivity * history of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis b, or haemophilus influenzae type b infection, confirmed either clinically, serologically, or microbiologically * known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances * known thrombocytopenia, as reported by the parent/legally acceptable representative * bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination * in an emergency setting, or hospitalized involuntarily * chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion * moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°c). a prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided * identified as a natural or adopted child of the investigator or employee with direct involvement in the proposed study * history of seizures.

Keywords: diphtheria tetanus pertussis haemophilus influenzae type b infection hepatitis b dtap-ipv-hep - prp-t vaccine